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Black Box for Botox® – A Warning or Potential Legal Defense?

Last year, Botox, a medication containing Botulinum Toxin A, was routinely injected into over 2.5 million Americans and generated $1.3 billion in sales. All this despite reports that Botox could cause symptoms similar to botulism, loss of bladder control, blurred vision, trouble breathing, swallowing and talking (not because of the size of those lips). Certified Legal Nurse Consultants working for plaintiff and defense firms should be aware that on April 30, 2009, the FDA issued a statement that all botulinum toxin products (including Botox and Botox Cosmetic) carry a black box label warning as well as a risk evaluation and mitigation strategy (REMS).

FDA Approval Not a Shield from Damages

On March 4th the U.S. Supreme Court decided a case in favor of consumer rights, one that has the potential to reach further than first appearance. In the case of Wyeth v. Levine the Court upheld a $6.7 million dollar verdict in which the jury found that Wyeth’s label had inadequate warnings, thus ruling against the drug manufacturer Wyeth. In doing so, the court allowed state juries to award damages for harm done by unsafe drugs, even in cases where the drugs had been approved by the Food and Drug Administration (FDA).

Drugstore Cowgirl – Or How I Learned to Hate Darvon and Love Weightlifting

As I’ve grown older I’ve learned to appreciate the difficulty of keeping my body (and mind) in great physical (and mental) shape. I hit the gym three days a week to lift weights with a trainer. On the odd-date days I really stretch myself by doing yoga or speed-walking to the Starbucks a couple of miles from my home. As my age has increased so has my strength and muscle-mass. I only wish I’d been as dedicated when I was in nursing school.

*The opinions and statements made by Vickie Milazzo, the founder of Medical-Legal Consulting Institute, Inc. are based on her experiences and expertise, should not be applied beyond the specific context provided, and do not guaranty or project actual results. Vickie Milazzo is no longer involved in the operations or management of the business, but is involved as an independent education consultant.

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